FDA Panel to Consider Lap Band Expansion

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Thursday, December 2, 2010 — (ABC News: Health) –

By LARA SALAHI

Dec. 2, 2010

A U.S. Food and Drug Administration advisory committee convening Friday will consider a request by manufacturers of the Lap Band to allow the popular weight-loss device to be used on those who are less obese.

The request by Allergan, the same company that manufactures Botox, will likely prove to be a controversial one, as some say such an approval could push the band further into the realm of cosmetic elective surgery. And the fact that the chairwoman of the FDA committee considering the request owns stock in Allergan will likely do little to quell this controversy.

While the heads of FDA advisory panels do not vote, in this case, Dr. Karen Woods, the chairwoman of the FDA advisory committee making the determination, could stand to gain financially from an affirmative decision, according to ABC News chief health and medical editor, Dr Richard Besser.

“It is disturbing that the person who’s heading the review committee has stock in that company,” Besser told “Good Morning, America.” “Allergan has a lot to benefit if this is approved.”

Today, nearly 13 million Americans may qualify for Lap Band surgery, but if the FDA approves Allergan’s request, the number eligible for the procedure could spike to nearly 32 million.

In early November, Woods, a gastroenterologist, disclosed financial gains of $10,000 to $25,000 in Allergan stockholdings. Woods’ interests were disclosed publicly on the FDA’s website, and despite her standing, the FDA granted her a waiver to oversee Friday’s panel.

“On rare occasions and consistent with our standard procedures, FDA scientists believe the expertise of a particular scientist is important enough for a scientific advisory committee to justify a waiver for conflict of interest,” Meghan Scott, a spokeswoman for the FDA, wrote in a statement to ABC News. “FDA grants the waiver to assure that the panel has the right expertise to provide well-informed recommendations to the agency.”